Clinical Research Nurse

Medix™; Overland Park (KS); On-site; USD 41,000 - 62,000; Full time

Job summary

Medix Staffing Solutions, Inc. seeks an experienced Clinical Research Nurse (RN) to support a full-time, single-protocol asthma study in the Overland Park, KS area. The role combines nursing assessments, patient safety advocacy, trial coordination, and regulatory maintenance.

You will perform spirometry, manage ISF/IRB submissions, data entry in Veeva EDC, and ensure adherence to GCP and FDA guidelines. This is a project-based contract with standard 40-hour weeks, Monday to Friday.

Qualifications

• Active RN license (Kansas or compact multistate).
• 2+ years of experience as a Clinical Research Nurse/Coordinator in sponsor-funded trials.
• Strong nursing clinical assessment skills.
• Hands-on regulatory experience with ISF/IRB submissions.
• Experience with lab specimen processing and spirometry testing.
• Proficient with EHR and CTMS systems.
• Solid knowledge of FDA regulations, ICH guidelines, and Good Clinical Practice (GCP).

Responsibilities

• Recruitment and patient outreach to identify eligible participants.
• Obtain informed consent and prepare patients for visits.
• Perform nursing assessments and protocol procedures, including spirometry.
• Handle lab processing tasks and specimen workflow.
• Maintain regulatory documentation (ISF, IRB submissions, safety updates).
• Enter data in EDC systems (Veeva EDC) and manage scheduling/reminders.

Skills

Nursing assessment

Regulatory compliance

Lab processing

Spirometry testing

EHR/CTMS software

Job description

We are seeking an experienced, detail-oriented Clinical Research Nurse (RN) to support a full-time, dedicated pharmaceutical asthma study in the Overland Park, KS area. Sponsored by a leading global pharmaceutical sponsor, this role provides focused, single-protocol project support combining professional nursing assessments, patient safety advocacy, full-cycle clinical trial coordination, regulatory maintenance, and hands-on protocol procedures. It is a project-based temporary contracted role.

Responsibilities

• Recruitment & Patient Outreach: Execute clinical recruitment strategies including medical chart reviews, phone pre-screenings, media referral processing, community outreach, and physician referral networking.
• Patient Consenting & Visit Prep: Conduct the full informed consent and assent process with study participants, delivering protocol education and handling all clinical visit preparations according to strict protocol guidelines.
• Nursing Assessments & Clinical Procedures: Perform protocol-required spirometry (non-invasive breathing tests), monitor participant respiratory symptoms, assess for adverse events, and educate patients on investigational treatments and device adherence.
• Lab Processing: Handle protocol specimen/lab processing, centrifugation, packaging, and shipping preparation (Note: position focuses on lab processing; no phlebotomy or blood draws required).
• Regulatory Compliance: Manage essential regulatory documentation, including Investigator Site File (ISF) maintenance, IRB submissions, safety updates, and ongoing regulatory submittals in accordance with GCP/FDA standards.
• Data Entry & Administrative Workflows: Complete timely clinical data entry in Electronic Data Capture systems (Veeva EDC), oversee participant e-Diary compliance, manage source documentation, and execute scheduling and appointment reminders (RealTime).

Required Qualifications

• Active RN license (Kansas or compact multistate).
• 2+ years of experience as a Clinical Research Nurse, Clinical Research Coordinator, or Study Coordinator supporting sponsor-funded, pharmaceutical interventional trials.
• Strong nursing clinical assessment skills
• Regulatory Expertise: Hands-on experience managing ISF documentation and submitting to IRBs.
• Clinical/Lab Skills: Demonstrated experience with lab specimen processing and spirometry testing.
• Software Proficiency: Hands-on experience navigating different EHR and CTMS systems.
• Regulatory Knowledge: Deep understanding of FDA regulations, ICH guidelines, and Good Clinical Practice (GCP).
• Lab Processing experience is needed!

Preferred Qualifications

• Prior experience coordinating Asthma, Respiratory, Pulmonology, or Immunology clinical trials.
• Familar with RealTime or Veeva.

Schedule & Logistics

• Role Type: Full-time, temporary/project-based contract (40 hours per week).
• Schedule: Standard day shift, Monday through Friday, 8:00 AM – 5:00 PM (Strictly no evenings or weekends).
• May be eligible to enroll in benefits, but enrollment must be requested and completed before starting work.